IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma
Trial ID or NCT#
This is an open label, multi-cohort, and multi-center phase II study, which evaluates the clinical activity and safety of IPH4102 in Sezary Syndrome and Mycosis fungoides as single agent.
TELLOMAK: T-cell Lymphoma Anti-KIR3DL2 Therapy. An Open Label, Multicohort, Multi-center Phase II Study Evaluating the Efficacy and Safety of IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T-cell Lymphoma
- 1. Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening; 2. Receipt of live vaccines within 4 weeks prior to treatment; 3. Central nervous system (CNS) lymphoma involvement; 4. Prior administration of IPH4102; 5. Concurrent enrollment in another clinical trial, unless it is an observational (non - interventional) clinical study or the follow-up period of an interventional study; 6. Autologous stem cell transplantation less than 3 months prior to enrollment; 7. Prior allogenic transplantation; 8. Patients who have undergone major surgery ≤ 4 weeks prior to study entry; 9. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection; 10. Patients who have Hepatitis B Virus infection determined as HBsAg positive and / or Hepatitis C Virus infection determined as detection of HCV RNA in serum or plasma by a sensitive quantitative molecular method; 11. Known or tested positive for human immunodeficiency virus (HIV); 12. Patients with a history of other malignancies during the past five years apart from the disease subject of this study. The following are exempt from the five-year limit: non-melanoma skin cancer, lymphomatoid papulosis, resected thyroid cancer, biopsy-proven cervical intraepithelial neoplasia, Ductal carcinoma in situ (DCIS) or cervical carcinoma in situ 13. Pregnant or breastfeeding women; 14. Known clinically significant cardiovascular disease or condition, including: - Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) Functional Classification; - Any uncontrolled arrhythmia (per the investigator's discretion); - Uncontrolled hypertension (per the investigator's discretion). 15. Patients with autoimmune disease on systemic immunosuppressive treatment; 16. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol; 17. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
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Elle (Hyunjin) Kim
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